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About the Role

The Compliance & Records Management, QAII is responsible for site QA Compliance, Internal/External Audits, Site Audit Readiness and all aspects of hosting Audits, Regulatory Intelligence (GOC), Management of the Global Entity review and Periodic Review processes, QA site Model, and other Quality System items as assigned. Main responsibilities include ensuring compliance with Regulations and corporate processes. Additional responsibilities related to Records Management include serving as the Site Records Management Coordinator and Subject Matter Expert.

Responsibilities

Ensuring compliance with Regulations and corporate processes to achieve desired business results.
Developing and sustaining the Quality Management System in line with regulatory, industry (ISO 13485), and business requirements.
Ensuring conformance to regulations per FDA Quality System Regulation (21CFR Part 820), ISO 13485:2016, Canadian Medical Devices Regulations SOR/98-282, and applicable Baxter Global Policies and Procedures.
Managing site certifications and external registration requirements, liaising with external bodies.
Managing the audit lifecycle including planning, scheduling, notification, execution, hosting, reporting, response evaluation, clarification requests, and CAPA closure.
Writing, reviewing, analyzing, and revising Standard Operating Procedures (SOPs) and submitting procedural changes.
Serving as a Subject Matter Expert (SME) in Quality compliance, maintaining expertise in current regulatory requirements, and providing training and coaching.
Leading Audit Readiness efforts for the site and ensuring compliance to regulatory requirements.
Managing the site Internal Audit Program, participating in audits, qualifying/overseeing alternate auditors, and planning for corrective and preventive actions.
Managing Site Compliance programs such as Global Observation Certification, Global Entity Review, and Periodic Review.
Strategizing quality improvement activities in collaboration with other departments.
Managing self-activities to achieve defined quality goals efficiently, accurately, and timely.
Providing detailed analysis of QMS KPIs for management review meetings.
Balancing cost, quality, people, and delivery objectives to meet plant goals using the standard enterprise management system.
Ensuring KPIs are met by working to the overall plan, including management and reporting.
Supporting failure investigation activities (CAPA projects) to identify root causes, develop corrective/preventive actions, and approve CAPAs and NCRs.
Maintaining an inventory of stored Records.
Ensuring Records are indexed and tracked for ease of retrieval.
Ensuring Records are archived/stored in appropriate locations (electronic and physical).
Tracking storage submissions and retrieval activities for records with offsite storage providers.
Monitoring/adhering to Legal Hold Orders.
Annually evaluating Records for destruction eligibility.
Periodically reviewing trigger dates to enter known dates that have occurred.
Preparing and routing destruction eligibility reports/lists for review.
Destroying Records in a timely fashion upon approval, in compliance with Baxter’s policies and procedures.

Requirements

Bachelor’s degree required.
Minimum of 3+ years of experience in Quality with emphasis on oversight of regulation and compliance, or related field with a medical device/pharmaceutical company or similar regulated industry, preferred.
Must be experienced with interpreting quality system regulations.
Audit experience is preferred.
Working knowledge of Quality Systems and related requirements and standards, including 21 CFR Part 820, ISO 13485, preferred.
Knowledge of risk management, root cause analysis, corrective and preventive action, and document control.
Demonstrated use of quality and root cause analysis tools, principles, and methodologies including statistical tools.
Proficient with computers and in the use of Microsoft Office Suite.
Strong verbal/written communication skills, problem-solving, and personal conflict resolution skills.
Strong attention to detail with the ability to independently organize workload, perform under strict deadlines and changing priorities with minimal supervision.
Project management skills and ability to handle multiple projects concurrently.
Ability to communicate with all levels within the organization.
Ability to demonstrate responsiveness to customer needs, within job scope.
Knowledge of Food & Drug Administration (FDA) Regulations and application of Good Manufacturing Practices.
Comprehension of design methodology, product configuration, and complex manufacturing processes.
Ability to excel in a team-oriented environment.
Must be able to sit, stand, bend, stretch and walk throughout the workday.
Must be able to lift at least 20 lbs.
Work well under tight deadlines.
Wear a static protective smock and Personal Protective Equipment (PPE) at all times while in designated work areas.
Work in close proximity to other employees.
Work in an environment that is temperature and humidity controlled.
Applicants must be authorized to work for any employer in the U.S.
Unable to sponsor or take over sponsorship of an employment visa at this time.

Skills

Quality Management System
Regulatory Compliance
ISO 13485
FDA Quality System Regulation (21CFR Part 820)
Canadian Medical Devices Regulations SOR/98-282
Baxter Global Policies and Procedures
Audit Management
Standard Operating Procedures (SOPs)
Subject Matter Expert (SME)
Risk Management
Root Cause Analysis
Corrective and Preventive Action (CAPA)
Document Control
Statistical Tools
Microsoft Office Suite
Communication Skills
Problem Solving
Conflict Resolution
Attention to Detail
Workload Organization
Project Management
Good Manufacturing Practices (GMP)
Design Methodology
Product Configuration
Manufacturing Processes

Location

Medina, NY

Work Type

Onsite
Full-time

Experience Level

3+ years

Education Level

Bachelor's degree
MS in science/engineering a plus

Salary/Compensations

$88,000-$121,500 annually

Benefits

Medical coverage
Dental coverage
Basic life insurance
Accident insurance
Short-term disability insurance
Long-term disability insurance
Business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP) with company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off (20-35 days based on length of service)
Family and medical leaves of absence
Paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
Childcare benefits

About the Company

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives.
Together, our community is driven by a culture of courage, trust, and collaboration.
Every individual is empowered to take ownership and make a meaningful impact.
We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job—you will find purpose and pride.

Equal Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Know Your Rights: Workplace Discrimination is Illegal
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally.
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